Nxera Pharma Co., Ltd. · TSE:4565
Nxera Pharma — Investor Presentation (July 2025)
55 slides from Nxera Pharma's investor presentation, July 2025
Slide 1: Corporate Presentation
EXTERNAL NON-CONFIDENTIAL Corporate Presentation July 2025 | Nxera Pharma Co., Ltd. (TSE: 4565)
Slide 2: Disclaimer
The material that follows is a presentation of general background information about Nxera Pharma Co., Ltd and its subsidiaries (collectively, the “Company”) as of the date of this Disclaimer presentation. This material has been prepared solely for informational purposes and is not to be construed as
Slide 3: Agenda
Agenda 01 Business Overview 02 Strategic Roadmap 03 Our Pipeline 04 Japan/APAC Business 05 Our NxWave Platform 06 Financial Results 07 Appendix 3
Slide 4: Business Overview
Business Overview 01
Slide 5: We are Nxera Pharma
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX We are Nxera Pharma A technology-powered biopharma in pursuit of new specialty medicines to improve the lives of patients OVERVIEW PRODUCTS AND PROGRAMS PRODUCT FOCUS & SCIENCE Sales Market Size Of Product Focus $200m Annual Re
Slide 6: Not a traditional Japanese pharma
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Not a traditional Japanese pharma. We think and innovate globally, and specialize locally Global Drug Discovery Center Japan Operations Team ~200 team CEO Research Finance Chief of Staff Legal members Finance Development Operat
Slide 7: Strategic Roadmap
Strategic Roadmap 02
Slide 8: Our History
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Our History Strategic steps taken to build Nxera over the last two decades 2000s 2015 2023 2024 Launched a public company Out-licensed several programs to Elevated our status in the Tokyo dedicated to bringing innovation to glo
Slide 9: Building a fully integrated biopharma from Japan
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Building a fully integrated biopharma from Japan Accelerating growth to achieve our mission by leveraging business platform in Japan and UK Drug discovery / Clinical Commercialization Preclinical Early-stage Late-stage Our sour
Slide 10: Priority objectives for FY2025
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Priority objectives for FY2025 01 JPY 17 billion+ Net product sales (PIVLAZ® plus QUVIVIQ®) Commercial 02 Acquire/in-license at least one late-stage medicine for Japan/APAC (ex-China) Commercial Execute at least one new major p
Slide 11: Partner's Wave1 and Wave2 programs across growing disease areas
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Partner’s Wave 1 and Wave 2 programs are positioned across fast growing disease areas of healthcare MARKET SIZE (2030) WAVE1 (Potential Launch by 2030) WAVE2 (Potential Launch by 2035) Neurology P2 mGlu5 NAM P2 Ox2 agonist P3 M
Slide 12: Our 2030 vision: high growth, highly profitable Japanese biopharma
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Our 2030 vision is to build a high growth, highly profitable Japanese biopharma JPY Bn Royalties from WAVE1 + WAVE2 create step-change WAVE2 WAVE2 Royalty Royalty Potential royalty from next generation Only 1-2 launches from se
Slide 13: Our Pipeline
Our Pipeline Programs by Design 03
Slide 14: Major pipeline Overview (incl. projections)
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Major pipeline Overview (incl. projections) Discovery – Preclinical Phase 1 Phase 2 Phase 3 Filed Commercial 10+ PROGRAMS EP4 ant. NXE’732 1H 2025 Lucerastat A PIVLAZ® A IN-HOUSE Advanced solid tumors Fabry disease Cerebral vas
Slide 15: Major pipeline Overview (incl. key partner highlights)
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Major pipeline Overview (incl. key partner highlights） Discovery – Preclinical Phase 1 Phase 2 Phase 3 Filed Commercial 10+ PROGRAMS EP4 ant. NXE’732 Lucerastat A PIVLAZ® A IN-HOUSE Advanced solid tumors Fabry disease Cerebral
Slide 16: Major pipeline Overview (By business categories)
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Major pipeline Overview (By business categories) Discovery – Preclinical Phase 1 Phase 2 Phase 3 Filed Commercial 10+ PROGRAMS EP4 ant. NXE’732 Lucerastat A PIVLAZ® A IN-HOUSE Advanced solid tumors Fabry disease Cerebral vasosp
Slide 17: Looking ahead to potential catalysts in 2025
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Looking ahead to potential catalysts in 2025* ✓ : Progress in 2025 PROGRAM PARTNER TIMING EVENT ✓ Cenerimod Feb. 2025 Assignment of JAPAC rights ✓ TMP-301 (mGlu5 NAM) Mar. 2025 Phase 2 study start in alcohol use disorder ✓ NBI’
Slide 18: Key strategy for each business category
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Key strategy for each business category Maximize the value of each business and demonstrate synergies by conducting integrated development in future NxWaveTM platform driven Acquire or in-license for Japan ◼ Collaborate with ex
Slide 19: Japan/APAC Business
Japan/APAC Business Deliver innovation to patients in Japan/APAC 04
Slide 20: Japan will serve as our base to expand across APAC markets
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Japan will serve as our base to expand across APAC markets Commercial Japan is an attractive, established market with strong volumes Japan is the second Tailwinds from near- High quality clinical APAC is the second largest phar
Slide 21: PIVLAZ (clazosentan, an endothelin A antagonist)
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX PIVLAZ® (clazosentan, an endothelin A antagonist) Commercial Our first commercially available product for the prevention of cerebral vasospasm in patients with Aneurysmal Subarachnoid Haemorrhage (aSAH) Quarterly PIVLAZ® Net Sa
Slide 22: QUVIVIQ (daridorexant, dual orexin antagonist)
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX QUVIVIQTM (daridorexant, dual orexin antagonist “DORA”) Commercial DORA is rapidly establishing its position in the treatment paradigm for insomnia (Bn JPY) Lemborexant (Dayvigo) Zolpidem Others 100 Suvorexant (Belsomra) Eszopi
Slide 23: Quviviq Business structure Image for Nxera
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Quviviq Business structure Image for Nxera Commercial Profit starts from royalty and supply margin will be adding on in a few years Sales structure Profit structure for Nxera Product net sales Royalty + Product supply sales Pro
Slide 24: Full year product sales guidance
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Full year product sales guidance Commercial Target 13.0 - 14.0 Bn JPY (PIVLAZ) as net sales, and 4.0 - 5.0 Bn JPY (QUVIVIQ) as royalty and supply Target sales in FY2025 13.0 – 14.0 Bn JPY 4.0 – 5.0 Bn JPY +7% +220% (NHI Sales:1
Slide 25: Our NxWave Platform
Our NxWave Platform Cutting-edge Science 05
Slide 26: NxWave platform enables faster, cheaper and more precise drug discovery
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX NxWave platform enables faster, cheaper and more precise drug discovery Platform World-leading science and platform enables efficient drug discovery against difficult targets Conventional drug discovery Our drug discovery Appro
Slide 27: Number of Structures Solved and Deposited in PDB
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Number of Structures Solved and Deposited in PDB, Resolution by technology Platform The number of structures solved using Cryo-EM is increasing, X-ray crystallography has extremely high resolution Number of stricture solved by
Slide 28: Our platform enables precise design of GPCR models
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Our platform enables precise design of GPCR models Platform Only by performing detailed structural analysis can we design great drugs. Imprecise GPCR model: Standard Medicine Precise GPCR model: Optimized Medicine Poorly unders
Slide 29: Our track record of major licensing transactions
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Our track record of major licensing transactions speaks for itself… Platform Income from licensing provides a great source of non-dilutive financing to support our growth Balance of potential milestone income from Top 15 pharma
Slide 30: Hundreds of millions of dollars received, billions in potential
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX … hundreds of millions of dollars received, billions of dollars in potential to come Platform New collaboration and exclusive option to license agreement executed with Boehringer Ingelheim Upfront and Initial Potential Total Pa
Slide 31: Muscarinic program development
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Muscarinic program development. Platform Ph3 ongoing for our product NBI'568, which aims to be best-in-class, owing to its predecessor Cobenfy First clinical evidence for benefit of Positive KarXT Phase2 clinical Cerevel M4 PAM
Slide 32: Topline Results for Phase 2 Trial of M4 Agonist
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Topline Results for Phase 2 Trial of M4 Agonist Platform 20mg dose demonstrated statistically significant efficacy at Week 3, 4, 5 and 6 vs. placebo “The effects with the 20-milligram dose, you see statistical significance betw
Slide 33: Comparison of Study Sites and Duration with Known Muscarinic Programs
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Comparison of Study Sites and Duration with Known Muscarinic Programs Platform Mentioned in a presentation Phase 3 of NBI-568 will be one to one randomization and around 20 sites per study Neurocrine/Nxera Neurocrine/Nxera BMS/
Slide 34: Placebo effect
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Data comparison of placebo effects (Total PANSS) Platform Large number of study sites in a clinical trial of muscarinic program may be linked to a higher placebo response. 20 Emraclidine (Empower-3) 15 Emracridine (Empower-2) K
Slide 35: Safety: Adverse Events Risk
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Safety: Adverse Events Risk Platform The gastrointestinal and cardiovascular adverse events were higher than placebo in KarXT, but not on NBI-568 Gastrointestinal Cardiovascular Others (M2) (M3) NBI-568 Similar to Similar to So
Slide 36: Potential to expand the indications for our Muscarinic program
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Potential to expand the indications for our Muscarinic program Platform Creating different approaches to target M1 and M4; M4 agonist will start Ph2 trials in 2025 for bipolar disorder Next Step Program Mechanism Phase Potentia
Slide 37: Orexin Receptor 2 (OX2R) Agonists in development with partner Centessa
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Orexin Receptor 2 (OX2R) Agonists in development with partner Centessa Platform Three products in development; ORX750 could report PoC results as early as 2025 Significant commercial opportunity for best-in-class lead program O
Slide 38: TMP-301, an mGlu5 NAM being developed by TemperoBio
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX TMP-301, an mGlu5 NAM being developed by TemperoBio Platform Two clinical trials in alcoholism and cocaine disorder are ongoing in patients Economic Condition: Royalties: Mid to high single digits, Transaction: 2020 • Tempero B
Slide 39: PF'522, a GLP-1 agonist being developed by Pfizer
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX PF'522, a GLP-1 agonist being developed by Pfizer Platform Pfizer's target disease changed to chronic weight management from 1Q2025 financial materials Economic Condition: Milestones received: $34m, Total potential milestones:
Slide 40: Financial Results
Financial Results 06
Slide 41: Key financial indicators
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Key financial indicators NPJ/NPK product sales and cost base fully included in FY2024. Milestones increased due to progress of partnered programs Latest result Major factors (JPY million) 8,000 6,644 ◼ USD10m from Viatris for a
Slide 42: Breakdown of Q1 results
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Breakdown of Q1 results Business is progressing smoothly. Significant improvement in revenue from commercial Consolidated Consolidated (JPY million) Platform*1 ＋ Commercial*2 = P&L (Core) ＋ Non-core costs = P&L (IFRS) （YoY） （Yo
Slide 43: Full year cost guidance for FY2025
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Full year cost guidance for FY2025 Slight increase in R&D expenses with progression of programs into later stages of development and in-licensing of one or more late-stage candidates. Lower to flat SG&A expenses through streaml
Slide 44: Appendix
Appendix 07
Slide 45: Partnered pipeline (1/2)
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Partnered pipeline (1/2) Compound Target / Mechanism of Action Modality Indication Partner Disc. PCC Ph1 Ph2 Ph3 App Mkt Partnered Seebri® Breezhaler® LAMA SME COPD Ultibro® Breezhaler® LAMA+LABA SME COPD Enerzair® Breezhaler®
Slide 46: Partnered pipeline (2/2)
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Partnered pipeline (2/2) Compound Target / Mechanism of Action Modality Indication Partner Disc. PCC Ph1 Ph2 Ph3 App Mkt Co-development KY1051 CXCR4 mAb mAb Immuno-oncology (Not disclosed) AI-Augmented Drug Discovery SME Neurol
Slide 47: In-house pipeline
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX In-house pipeline Compound Target / Mechanism Modality Indication Partner Disc. PCC Ph1 Ph2 Ph3 App Mkt In-house Programs PIVLAZ® ETA antagonist SME Cerebral vasospasm QUVIVIQ Dual Orexin antagonist SME Insomnia NXE0048149 1 GP
Slide 48: Clinical Trials
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Clinical Trials Compound MoA Condition Phase Size Patient Start Completion* Last Update Link (main/latest) Link (others) NBI-1117568 M4 agonist Schizophrenia Ph2 210 Yes 2022-10-04 2024-07-10 2025-07-11 NCT05545111 - NBI-111756
Slide 49: Estimation of potential market size
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Estimation of potential market size Multi-billion USD annual peak sales potential for our post-pre-clinical pipeline Peak Sales Category Indication2 Number of Patients Candidates Market Size Individual Products Dementia ~55 mil
Slide 50: Exclusive Opt-in Rights And ROFN/ROFR
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Exclusive Opt-in Rights And ROFN/ROFR1 Option to develop up to five clinical programs for Japan and APAC (ex-China) from Idorsia Program Mechanism of Action Indication Stage Region Exclusive Lucerastat Glucosylceramide synthase
Slide 51: Core Operating Profit - Definition
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Core Operating Profit - Definition Core Operating Profit/Loss – a financial indicator closer to the reality of our business Operating Profit Operating Profit “Core” “IFRS” ◼ Core Operating Profit/ Loss is a key ◼ Financial resu
Slide 52: Exchange Rate, Intangible Assets and Non-core Costs
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Exchange Rate, Intangible Assets and Non-core Costs Average exchange rate during period Non-core costs (full year) (JPY mn) FY2025 FY2024 FY2023 FY2022 FY 2024 FY 2023 FY 2022 USD:JPY Actual - 151.43 140.53 131.30 Cost of sales
Slide 53: Glossary
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Glossary Basic Terminology/Technology GPCR G Protein-Coupled Receptor There are about 800 types of GPCRs in the human body. While 400 of them are known to be potential drug targets, about 300 of them are not yet drugged Nxera’
Slide 54: Locations
Locations Midtown East, F17, 410 Teheran- Steinmetz Building Spaces Grosspeter 9-7-2 Akasaka Ro Granta Park, Tower, Minato-ku GangHam-Gu Grosspeteranlage Cambridge 29, Tokyo 107-0052 Seoul 06192 CB21 6DG 4052 Basel Japan South Korea United Kingdom Switzerland 54
Slide 55: Thank you
Thank you BREAKTHROUGHS IN PROGRESS ● BREAKTHROUGHS IN PROGRESS ● BREAKTHROUGHS IN PROGRESS